AB1774-HPR SAFETY OF THE RECOMBINANT HERPES ZOSTER VACCINE IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH JAKI DRUGS
Authors: A. Pons-Bas, J. Rosas, L. Pons-Canet, J. M. Senabre-Gallego, G. Santos Soler, J. A. Bernal, J. C. Cortés-Quiroz, C. Raya-Santos, R. Gallego-Campuzano, M. Lorente Betoret, X. Barber, J. A. García-Gómez
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Patients receiving JAK inhibitor drugs (JAKi) have an increased risk of herpes zoster (HZ). A new recombinant vaccine effective against HZ (Shingrix-RV) is currently recommended for patients treated with JAKi. <h3>Objectives</h3> To evaluate the safety of first and second dose of the recombinant vaccine against HZ (HZ-RV) in patients with RA, in treatment with JAKi. <h3>Methods</h3> Retrospective study of the safety after receiving the first and after 2 months, second dose of the HZ-RV in patients with RA treated with JAKi. The following variables were collected: general information of the patients, type of JAKi and time in treatment; use and dosage of DMARDcs drugs and/or corticosteroids. Regarding HZ: infection prior to HZ-RV and time elapsed; occurrence and type of side effects after vaccination. <h3>Results</h3> Of 138 patients treated with JAKi, 9 (7%) refused vaccination, 129 (93%) received the first dose on HZ-RV, but 38 (28%) patients received it before starting JAKi and 98 (72%) being a mean of 36 months in treatment with JAKi. The second dose was administered in 113 (82%) patientes, 21 (15%) patients had suffered HZ, before vaccination. One hundred and eight (84%) are female (mean age: 64 [SD: 3] years), on JAKi treatment a mean of: 2.4 (SD: 1.6) years: 89 (69%) baricitinib (2 mg/day: 29 [33%] patients; 4 mg/day: 60 [67%]), upadacitinib: 48 (44%) and 3 (3%) patients with tofacitinib. Eighty seven (67%) patients were receiving DMARDcs: methotrexate: 55 (63%), mean weekly dose: 17.5 mg (SD: 3.5), leflunomide: 22 (25%), hydroxychloroquine: 8 (9%), sulfasalazine: 2 (2%). Fity six (40%) patients received prednisone: mean daily dose: 5.2 mg (SD: 1.8). During one month after first dose of vaccine, 97 (75%) and 62 (55%) after second dose had side effects (p=0.68): local pain: 95 (74%) vs 62 (55%) patients, p=0.014; fatigue: 27 (21%) vs 15 (13%), p=0.17; arthralgia-myalgia: 21 (19%), p=0.17; fever &lt; 38ºC: 10 (8%) vs 15 (13%), p=0.69; headache: 9 (7%) vs 3 (3%), p=0.72; local itching: 3 (2%) vs 2 (2%), gastrointestinal symptoms: 2 (2%) vs 2 (3%), p=0.943; and after first dose, others in 4 (4%) patients: urinary tract infection, oral ulcer, dizziness, injection site erythema. Lymphadenopathy, hospital admission, flare of RA or serious secondary effects were not detected. After 90 days of second vaccine, a 58-year-old woman (0.8%) undergoing 5-month treatment with baricitinib 4 mg/day and methotrexate, without corticosteroids, presented a slight facial HZ reactivation dose. <h3>Conclusion</h3> 1. Vaccination with HZ-RV was safe. 2. Although a great percentage of pacients have experienced any side effect, especially after the first dose of vaccine, these were mild. 3. No flare of RA has been detected in this period. 4. Less than 1% of patients suffered HZ reactivation after vaccination. <h3>Acknowledgements</h3> The study was supported by a research grant from the Marina Baixa Association for Research in Rheumatology (AIRE-MB). <h3>Disclosure of Interests</h3> None Declared.